If a participant fails to respond in their initial Step 3 dosing interval, they can be eligible to repeat Step 3. They can re-enter or repeat Step 3 one time only. They will only re-enter Step 3 to test a longer dosing interval. Again, if > 60 days elapses between the final safety visit of step 3 (Visit 7) and their re-entry to Step 3, they will re-screen (visit 1 only) to qualify to continue in the study.